ENERZAIR BREEZHALER

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Units in package:

DUS, 3 BLISTER @ 10 KAPSUL + 1 INHALER

Authorization date:

2022-06-28

Summary of Product characteristics

ENERZAIR
® BREEZHALER
®
(indacaterol acetate, glycopyrronium bromide, and
mometasone furoate fixed-dose combination)
inhalation powder hard capsules
PRODUCT INFORMATION
(draft v6)
Based on CDS version 1.3 ( 11-Mar-2021)
DISETUJUI BPOM 6 JUNI 2022
EREG10000512000199
1
TRADENAME(S)
ENERZAIR
®
BREEZHALER
®
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Indacaterol/glycopyrronium/mometasone furoate 150/50/160 micrograms,
inhalation powder,
hard capsules.
Capsules with green transparent cap and uncolored transparent body
containing a white powder
with the product code “IGM 150-50-160” printed in black above two
black bars on the body
and with the product logo printed in black and surrounded by a black
bar on the cap.
ACTIVE SUBSTANCE(S)
Each capsule of Enerzair Breezhaler 150/50/160 micrograms contains 173
micrograms of
indacaterol
acetate
equivalent
to
150
micrograms
of
indacaterol,
63
micrograms
of
glycopyrronium bromide equivalent to 50 micrograms glycopyrronium and
160 micrograms
mometasone furoate. Each delivered dose (the dose that leaves the
mouthpiece of the inhaler)
contains 114 mcg of indacaterol (as acetate), 58 mcg of glycopyrronium
bromide equivalent to
46 mcg of glycopyrronium and 136 mcg of mometasone furoate.
EXCIPIENTS
Capsule fill: lactose monohydrate, magnesium stearate.
Capsule shell components: hypromellose, purified water, carrageenan,
potassium chloride.
Each capsules contains 25 mg of lactose monohydrate.
3
INDICATIONS
ENERZAIR BREEZHALER (indacaterol / glycopyrronium / mometasone
furoate) is indicated
as a maintenance treatment of asthma in adult patients not adequately
controlled with a
maintenance combination of a long-acting beta2-agonist and a medium or
high dose of an
inhaled corticosteroid who experienced one or more asthma
exacerbations in the previous 12
months.
ENERZAIR BREEZHALER is not indicated for the relief of acute
bronchospasm.
DISETUJUI BPOM 6 JUNI 2022
EREG10000512000199
4
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
Inhalation of t